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The Tanzania Trade Portal is managed by the Tanzania Trade Development Authority (TanTrade) under the auspices of the National Trade Facilitation Committee (NTFC)

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Summary

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"Certification sheet" format

Steps (35)

Obtain medical device or in vitro diagnostic registration certificate (6)

1 Register and apply for medical device or in vitro diagnostic registration certificate

2 Pay registration fees

3 Obtain TMDA receipt

4 Submit technical file (dossier)

5 Obtain registration notification

6 Obtain medical device or in vitro diagnostics registration certificate

Obtain registration certificate of premises for medical and in vitro diagnostic devices (5)

7 Submit application for premise registration

8 Pay registration and inspection fees

9 Obtain TMDA receipt

10 Inspection of premise

11 Obtain registration documents

Obtain medical devices or in vitro diagnostics import permit (3)

12 Apply for import permit

13 Pay for medical device or in vitro diagnostics import permit

14 Obtain medical device or in vitro diagnostics import permit

Obtain certificate of radioactivity analysis (3)

15 Apply for radioactivity analysis certificate

16 Pay fee

17 Obtain radioactivity analysis certificate

Pre-clearance documentation (1)

18 Contract a clearing agent

Custom declaration (3)

19 Lodge custom documents (TRA)

20 Pay custom levy

21 Obtain Tanzania Single Administrative Document (TANSAD)

Verification of consignment (3)

22 Book for physical verification of consignment

23 Pay container freight station (CFS ) charges

24 Physical verification of consignment

Obtain TRA release order (2)

25 Submit stamped documents

26 Obtain release order

Obtain delivery order (3)

27 Submit bill of lading

28 Pay shipping line charges

29 Obtain delivery order

Port clearance (6)

30 Lodge cargo clearance documents (TPA)

31 Pay port charges

32 Create truck announcement

33 Obtain gate in ticket

34 Cargo collection and security verification

35 Check point and gate out pass

2

Pay registration fees
(last modified: 08/12/2021)

You can pay for this step online

Pay online

Costs

( see details )

Timeframe ( see details )

USD 9,375

0 mn - 25 mn

Contact details

Entity in charge

Bank

Unit in charge

Bank hall

Mon:	08:00 - 16:30
Tue:	08:00 - 16:30
Wed:	08:00 - 16:30
Thu:	08:00 - 16:30
Fri:	08:00 - 16:30
Sat:	08:30 - 12:00

NMB and TIB bank Dar es salaam ports branches works 24 hours 7 days.

Person in charge

Bank Teller

List of banks and bank accounts

Expected results

Stamped bank deposit slip

Requirements

1.

TMDA profoma invoice

Cost USD 850

TZS

TZS Add Name Here

Registration of imported medical devices
USD 500 For medical device Class A non-exempted from registration
or USD 2,500 For medical devices class B, C and D
or USD 150 Variation-minor
or USD 300 Variation-major
or USD 200 Retention- Class A, B, C and D
Other costs
Registration of imported in vitro diagnostic devices
USD 350 Class A
or USD 1,250 Class B
or USD 1,500 Class C
or USD 2,000 Class D
or USD 125 Variation-minor
or USD 250 Variation-major
or USD 250 Retention

Payment methods: cash, check, Mobile money

For Mpesa, Dial *150*00# .For Tigopesa, Dial *150*01# . For Airtelmoney, Dial *150*60#. For Halopesa, Dial *150*88#. Select government payment, payment number will be the control number. The payment number for both platforms is the valid control number obtained from the Tanzania Medicines and Medical devices Authority (TMDA). Payments can also be made through banks using the control number.

Time frame

Waiting time in queue: Max. 20mn

Attention at counter: Max. 5mn

Legal justification

1.

Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015
Section 122(1)(i))schedule42-80

Additional information

Variation means a change to any aspect of a pharmaceutical product, including but not limited to a change to formulation, method, site of manufacture, specifications for the finished product, ingredients, container and container labeling and product information.